Cover -- Contents -- Introduction -- General -- Strategic directions in biological standardization -- Vaccines and biological therapeutics: recent and planned activities in biological standardization -- Blood products and related in vitro diagnostics: recent and planned activities in biological standardization -- Blood Regulators Network -- Reports from the WHO international laboratories and collaborating centres for biological standards -- National Institute for Biological Standards and Control, Potters Bar, England -- WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices, Paul-Ehrlich-Institute, Langen, Germany -- Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, Bethesda, USA -- Reports from international groups establishing secondary standards -- Issues shared with the WHO Expert Committee on Specifications for Pharmaceutical Preparations -- Pharmaceutical cold-chain management -- Nomenclature of stem cells -- International Recommendations, Guidelines, and other matters related to the manufacture and quality control of biologicals -- Guidelines for independent lot release of vaccines by regulatory authorities -- Guidelines on evaluation of similar biotherapeutic products (SBPs) -- Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines -- Recommendations to assure the quality, safety and efficacy of live attenuated influenza vaccines -- Good manufacturing practices for manufacturing blood products for transfusion -- Convalescent plasma -- Snake bite envenomings and antivenoms -- International reference materials - antigens and related substances -- Inactivated poliovirus vaccines (trivalent) -- Poliovirus type 1 (Sabin) -- Human papillomavirus type 16 antibodies -- Bordetella pertussis serotype 2 and serotype 3 -- BCG vaccine.

Diphtheria vaccine (adsorbed) -- International reference materials - blood products and related substances -- International Society on Thrombosis and Haemostasis report -- Blood coagulation factor VIII, concentrate -- Blood coagulation factor VIII and von Willebrand factor (VWF), plasma -- Streptodornase -- Unfractionated heparin -- International reference materials - cytokines, growth factors and endocrinological substances -- Chorionic gonadotrophin, human -- Parathyroid hormone, 1-84, human recombinant -- International reference materials - diagnostic reagents -- HIV-2 RNA -- Hepatitis B virus DNA -- Parvovirus B19 DNA -- Thromboplastin, human, recombinant plain -- Soluble transferrin receptor -- Prader-Willi and Angelman syndromes -- Fusion gene BCR-ABL -- Proposed new reference preparation projects -- Antigens and related substances -- Human papillomavirus (HPV) type 6 DNA and type 11 DNA - proposed International Standards -- Purified human genomic DNA -- Typhoid antibodies - proposed International Standards -- Antibodies (human) to influenza A virus - proposed International Standards -- Antibodies (human) to pneumococcal polysaccharides - proposed International Standard -- Mycoplasma DNA - proposed International Standard -- WHO Vero reference cell bank 10-87 - proposed replacement cell bank -- Anti-malaria IgG - proposed International Standard -- Blood products and related substances -- Transfusion-relevant bacterial strain panel -- Fibrinogen, plasma -- Fibrinogen, concentrate -- Low molecular weight (LMW) heparin -- Cytokines, growth factors and endocrinological substances -- Follicle-stimulating hormone - proposed Second International Standard -- Granulocyte Colony-Stimulating Factor - proposed Second International Standard -- Granulocyte Colony-Stimulating Factor - proposed Second International Standard.

Insulin, human, recombinant - proposed International Standard -- Diagnostic reagents -- HIV-1 RNA for NAT-based assays -- Antibodies to human T-lymphotropic virus type 1 (HTLV-1) and type 2 (HTLV-2) -- Dengue virus RNA for NAT-based assay reference panel -- West Nile Virus RNA for NAT-based assays -- Hepatitis C virus (HCV) core antigen -- Hepatitis D virus RNA for NAT-based assays -- Hepatitis E virus (HEV) RNA for NAT-based assays -- Toxoplasma gondii DNA for NAT-based assays -- Anti-toxoplasma antibody IgM, human -- BK virus DNA for NAT-based assays -- JC virus DNA for NAT-based assays -- Apolipoprotein B reagent -- Antibodies to dsDNA (human serum) -- Ongoing stability monitoring for WHO international standards -- Annex 1 Recommendations, Guidelines and other documents for biological substances used in medicine -- Annex 2 Guidelines on evaluation of similar biotherapeutic products (SBPs) -- Annex 3 Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines -- Annex 4 Recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administration -- Annex 5 Biological substances - International Standards and Reference Reagents.